Bio Amp Owner's Guide

50 Pages·2005·0.79 MB·English

Bio Amp
Owner’s Guide
This document was, as far as possible, accurate at the time of release. However, changes
may have been made to the software and hardware it describes since then.
ADInstruments Pty Ltd reserves the right to alter specifications as required. Late-
breaking information may be supplied separately.
Trademarks of ADInstruments
PowerLab®, LabChart®, LabTutor®, LabAuthor® and MacLab® are registered trademarks of
ADInstruments Pty Ltd. The names of specific recording units, such as PowerLab 8/30, are
trademarks of ADInstruments Pty Ltd. LabTutor Server, Chart and Scope (application
programs) and LabTutor Online are trademarks of ADInstruments Pty Ltd.
Other Trademarks
Apple, Mac and Macintosh are registered trademarks of Apple Computer, Inc.
Windows, Windows 7, Windows Vista and Windows XP are either registered trademarks
or trademarks of Microsoft Corporation.
All other trademarks are the property of their respective owners.
Product: ML132 Bio Amp; ML135 Dual Bio Amp; ML138 Octal Bio Amp
Document Number: U-ML132-OG-004C
Part Number: 4377
Copyright © December 2009 ADInstruments Pty Ltd.
Unit 13, 22 Lexington Drive, Bella Vista, NSW 2153, Australia
All rights reserved. No part of this document may be reproduced by any means without
the prior written permission of ADInstruments Pty Ltd.
Web: www.adinstruments.com
Technical Support: [email protected]
Documentation: [email protected]
ADInstruments Pty Ltd. ISO 9001:2000 Certified Quality Management System
Reg. No. 1053
ii Bio Amp Owner’s Guide
Contents
Safety Notes 5
1 Overview 11
How to Use This Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Checking the Front-end . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Front-end Fundamentals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
The Front-end . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
The Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
The Input Socket . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
The Status Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Audio Out Socket . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
The Back Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
I2C Input and Output Sockets . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Analog Output Sockets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Audio Out Socket . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
The Bio Amp Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Types of Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Recording Technique . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2 Setting Up 21
Connecting to the PowerLab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Using More Than One Bio Amp . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Using ADInstruments Programs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
The Front-end Driver. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
The Bio Amp Self-test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Software Behavior. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
The Bio Amp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Signal Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Setting the Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Filtering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
EEG Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Inverting the Signal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
DC Restore . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
iii
Contents
A Technical Aspects 29
Bio Amp Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Technical Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
The Bio Amp Cable Input . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
B Troubleshooting 35
Problems and Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
C Specifications 39
Single Bio Amp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Input. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Filtering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Control Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Physical Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Dual Bio Amp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Input. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Filtering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Control Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Physical Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Octal Bio Amp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Input. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Filtering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Control Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Physical Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Emmisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Separation Distances. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Index 49
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Bio Amp Owner’s Guide
Safety Notes
Statement of Intended Use
All products manufactured by ADInstruments are intended for use in
teaching and research applications and environments only. ADInstruments
products are NOT intended to be used as medical devices or in medical
environments. That is, no product supplied by ADInstruments is intended to
be used to diagnose, treat or monitor a subject. Furthermore no product is
intended for the prevention, curing or alleviation of disease, injury or
handicap.
Where a product meets IEC 60601-1 it is under the principle that:
• it is a more rigorous standard than other standards that could be chosen,
and
• it provides a high safety level for subjects and operators.
The choice to meet IEC 60601-1 is in no way to be interpreted to mean that a
product:
• is a medical device,
• may be interpreted as a medical device, or
• is safe to be used as a medical device.
Safety Symbols
Devices manufactured by ADInstruments that are designed for direct
connection to humans are tested to IEC 601-1:1998 (including amendments 1
and 2) and 60601-1-2, and carry one or more of the safety symbols below.
These symbols appear next to those inputs and output connectors that can be
directly connected to human subjects.
Safety Notes 5
!
BF symbol: Body- CF symbol: Cardiac-
Warning symbol: ‘see
protected equipment protected equipment
documentation’
The three symbols are:
• BF (body protected) symbol. This means that the input connectors are
suitable for connection to humans provided there is no direct electrical
connection to the heart.
• CF (cardiac protected) symbol. This means that the input connectors are
suitable for connection to human subjects even when there is direct
electrical connection to the heart.
• Warning symbol. The exclamation mark inside a triangle means that the
supplied documentation must be consulted for operating, cautionary or
safety information before using the device.
Further information is available on request.
Bio Amp Safety Instructions
The Bio Amp inputs displaying any of the safety symbols are electrically
isolated from the mains supply in order to prevent current flow that may
otherwise result in injury to the subject. Several points must be observed for
safe operation of the Bio Amp:
• All Bio Amp front-ends (except for the ML138 Octal Bio Amp) and
PowerLab units with a built-in Bio Amp are supplied with a 3-lead or 5-
lead Bio Amp subject cable and lead wire system. The ML138 Octal Bio
Amp is supplied with unshielded lead wires (1.8 m). Bio Amps are only
safe for human connection if used with the supplied subject cable and lead
wires.
• All Bio Amp front-ends and PowerLab units with a built-in Bio Amp are
not defibrillator-protected. Using the Bio Amp to record signals during
defibrillator discharges may damage the input stages of the amplifiers.
This may result in a safety hazard.
• Never use damaged Bio Amp cables or leads. Damaged cables and leads
must always be replaced before any connection to humans is made.
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Bio Amp Owner’s Guide
Isolated Stimulator Safety
Instructions
The Isolated Stimulator outputs of a front-end signal conditioner or PowerLab
with a built-in isolated stimulator are electrically isolated. However, they can
produce pulses of up to 100 V at up to 20 mA. Injury can still occur from
careless use of these devices. Several points must be observed for safe
operation of the Isolated Stimulator:
• The Isolated Stimulator output must only be used with the supplied bar
stimulus electrode.
• The Isolated Stimulator output must not be used with individual
(physically separate) stimulating electrodes.
• Stimulation must not be applied across the chest or head.
• Do not hold one electrode in each hand.
• Always use a suitable electrode cream or gel and proper skin preparation
to ensure a low-impedance electrode contact. Using electrodes without
electrode cream can result in burns to the skin or discomfort for the
subject.
• Subjects with implantable or external cardiac pacemakers, a cardiac
condition, or a history of epileptic episodes must not be subject to
electrical stimulation.
• Always commence stimulation at the lowest current setting and slowly
increase the current.
• Stop stimulation if the subject experiences pain or discomfort.
• Do not use faulty cables, or those that have exhibited intermittent faults.
• Do not attempt to measure or record the Isolated Stimulator waveform
while connected to a subject using a PowerLab input or any other piece of
equipment that does not carry the appropriate safety symbol (see Safety
Symbols above).
Always check the status indicator on the front panel. It will always flash green
each time the stimulator delivers a current pulse. A yellow flash indicates an
‘out-of-compliance’ (OOC) condition that may be due to the electrode contact
drying up. Always ensure that there is good electrode contact at all times.
Electrodes that are left on a subject for some time need to be checked for dry
contacts. An electrode impedance meter can be used for this task.
• Always be alert for any adverse physiological effects in the subject. At the
first sign of a problem, stimulation must be stopped, either from the
software or by flicking down the safety switch on the front panel of any
built-in Isolated Stimulator or the ML180 Stimulus Isolator.
Safety Notes 7
• The ML180 Stimulus Isolator is supplied with a special transformer plug
pack. The plug pack complies with medical safety requirements.
Therefore, under no circumstances should any other transformer be used
with the Stimulus Isolator. For a replacement transformer plug pack please
contact your nearest ADInstruments representative.
General Safety Instructions
To achieve the optimal degree of subject and operator safety, consideration
should be given to the following guidelines when setting up a PowerLab
system either as stand-alone equipment or when using PowerLab equipment
in conjunction with other equipment. Failure to do so may compromise the
inherent safety measures designed into PowerLab equipment. The following
guidelines are based on principles outlined in the international safety
standard IEC60601-1-1: General requirements for safety - Collateral standard:
Safety requirements for medical systems. Reference to this standard is required
when setting up a system for human connection.
PowerLab systems (and many other devices) require the connection of a
personal computer for operation. This personal computer should be certified
as complying with IEC60950 and should be located outside a 1.8 m radius
from the subject (so that the subject cannot touch it while connected to the
system). Within this 1.8 m radius, only equipment complying with IEC60601-
1 should be present. Connecting a system in this way obviates the provision of
additional safety measures and the measurement of leakage currents.
Accompanying documents for each piece of equipment in the system should
be thoroughly examined prior to connection of the system.
While it is not possible to cover all arrangements of equipment in a system,
some general guidelines for safe use of the equipment are presented below:
• Any electrical equipment which is located within the SUBJECT AREA
should be approved to IEC60601-1.
• Only connect those parts of equipment that are marked as an APPLIED
PART to the subject. APPLIED PARTS may be recognized by the BF or CF
symbols which appear in the Safety Symbols section of these Safety Notes.
• Only CF-rated APPLIED PARTS must be used for direct cardiac
connection.
• Never connect parts which are marked as an APPLIED PART to those
which are not marked as APPLIED PARTS.
• Do not touch the subject to which the PowerLab (or its peripherals) is
connected at the same time as making contact with parts of the PowerLab
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Bio Amp Owner’s Guide
(or its peripherals) that are not intended for contact to the subject.
• Cleaning and sterilization of equipment should be performed in
accordance with manufacturer’s instructions. The isolation barrier may be
compromised if manufacturer’s cleaning instructions are not followed.
• The ambient environment (such as the temperature and relative humidity)
of the system should be kept within the manufacturer’s specified range or
the isolation barrier may be compromised.
• The entry of liquids into equipment may also compromise the isolation
barrier. If spillage occurs, the manufacturer of the affected equipment
should be contacted before using the equipment.
• Many electrical systems (particularly those in metal enclosures) depend
upon the presence of a protective earth for electrical safety. This is
generally provided from the power outlet through a power cord, but may
also be supplied as a dedicated safety earth conductor. Power cords should
never be modified so as to remove the earth connection. The integrity of
the protective earth connection between each piece of equipment and the
protective earth should be verified regularly by qualified personnel.
• Avoid using multiple portable socket-outlets (such as power boards)
where possible as they provide an inherently less safe environment with
respect to electrical hazards. Individual connection of each piece of
equipment to fixed mains socket-outlets is the preferred means of
connection.
If multiple portable socket outlets are used, they are subject to the following
constraints:
• They shall not be placed on the floor.
• Additional multiple portable socket outlets or extension cords shall not be
connected to the system.
• They shall only be used for supplying power to equipment which is
intended to form part of the system.
Cleaning and Sterilization
ADInstruments products may be wiped down with a lint free cloth moistened
with industrial methylated spirit. Refer to the manufacturer’s guidelines or the
Data Card supplied with transducers and accessories for specific cleaning and
sterilizing instructions.
Safety Notes 9
Preventative Inspection and
Maintenance
PowerLab systems and ADInstruments front-ends are all maintenance-free
and do not require periodic calibration or adjustment to ensure safe
operation. Internal diagnostic software performs system checks during power
up and will report errors if a significant problem is found. There is no need to
open the instrument for inspection or maintenance, and doing so within the
warranty period will void the warranty.
Your PowerLab system can be periodically checked for basic safety by using
an appropriate safety testing device. Tests such as earth leakage, earth bond,
insulation resistance, subject leakage and auxiliary currents and power cable
integrity can all be performed on the PowerLab system without having to
remove the covers. Follow the instructions for the testing device if performing
such tests.
If the PowerLab system is found not to comply with such testing you should
contact your PowerLab representative to arrange for the equipment to be
checked and serviced. Do not attempt to service the device yourself.
Environment
Electronic components are susceptible to corrosive substances and
atmospheres, and must be kept away from laboratory chemicals.
Storage Conditions
• Temperature in the range 0–40 °C
• Non-condensing humidity in the range 0–95%.
Operating Conditions
• Temperature in the range 5–35 °C
• Non-condensing humidity in the range 0–90%.
Disposal
• Forward to recycling center or return to manufacturer.
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Bio Amp Owner’s Guide